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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX NERVE BLOCK TRAY (KIT)

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B. BRAUN MEDICAL INC. CONTIPLEX NERVE BLOCK TRAY (KIT) Back to Search Results
Model Number 331641
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/03/2020
Event Type  Malfunction  
Manufacturer Narrative

This report has been identified as b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.

 
Event Description

As reported by the user facility: description of issue: on (b)(6) 2020, patient received a femoral nerve block. On (b)(6) 2020, the catheter was removed and 1 cm of the blue tip was noted to be missing. It appeared that the tip was sheared off. An x-ray was done and no catheter was seen. No redness, tenderness, swelling was noted at the site. Surgeon was consulted and it was recommended to monitor the site. No additional treatments were performed.

 
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Brand NameCONTIPLEX
Type of DeviceNERVE BLOCK TRAY (KIT)
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown, pa
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, pa 
7197287
MDR Report Key9720667
MDR Text Key180420010
Report Number2523676-2020-00012
Device Sequence Number1
Product Code OGJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number331641
Device Catalogue Number331641
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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